Heart valve sizing ring and method

ABSTRACT

A device for measuring heart valve for sizing a heart valve reinforcement ring, includes a handle having a first shaft and a second shaft; an inner ring coupled to the first shaft; an outer ring coupled to the second shaft; and a trigger mechanism configured and arranged to force the inner ring and outer ring together wherein an outer surface of the inner ring engages an inner surface of the outer ring; the inner surface of the outer ring and the outer surface of the inner ring having reciprocal mating surfaces configured and arranged to grip sutures therebetween when coupled together.

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent document claims priority to earlier filed U.S.Non-Provisional application Ser. No. 13/658,050, filed on Oct. 23, 2012,which claims priority to U.S. Provisional Application Ser. No.61/551,728, filed on Oct. 26, 2011, and U.S. Provisional ApplicationSer. No. 61/555,002, filed on Nov. 3, 2011, the entire contents of whichare incorporated herein by reference.

BACKGROUND 1. Technical Field

The present patent document relates generally to heart valve repair inopen heart surgery and more specifically to a heart valve sizing ringand method to properly size a heart valve reinforcement ring prosthesisfor proper implantation.

2. Background of the Related Art

Accurate selection of ring size and shape is a critical component ofheart valve repair surgery. Current “annulus-sizers” or “valve-sizers”are, by design, not very accurate at actually assessing size (they onlyprovide an estimate) and, certainly, provide no ability for physiologicassessment of the repair procedure in terms of valve function afterrepair.

Therefore, there is a perceived need in the industry for a ring sizingtool that allows the surgeon to accurately assess the size of the ringprosthesis needed and allows assessment of the fit on the patient, i.e.whether the fit is leaky or too tight.

SUMMARY

The present invention solves the problems of the prior art by providinga ring sizing tool that includes an outer ring portion with small gapformed therethrough and an inner mating surface on the interior portionof the ring. An inner ring is sized to snap fit into the outer ring andincludes a reciprocal mating surface designed to engage the inner matingsurface of the outer ring yet prevent damage to sutures. The reciprocalsurface preferably includes an outwardly deflected portion to directsutures away from the heart valve.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features, aspects, and advantages of the presentinvention will become better understood with reference to the followingdescription, appended claims, and accompanying drawings where:

FIG. 1 is a perspective view of an embodiment of a heart valve ringsizing tool of the present invention;

FIG. 2 is an exploded view of an embodiment of a heart valve ring sizingtool of the present invention;

FIG. 3 is a cross-section view through line 3-3 of FIG. 2;

FIG. 4 is a perspective view of the sutures being gathered within theouter ring an embodiment of a heart valve ring sizing tool of thepresent invention;

FIG. 5 is a perspective view showing of an embodiment of a heart valvering sizing tool of the present invention in place over a heart valvewith the sutures trapped between the outer and inner rings;

FIG. 6 is a cross-section view through line 6-6 of FIG. 5;

FIG. 7 is a perspective view of an alternative embodiment of the heartvalve ring sizing tool of the present invention with the ringsseparated;

FIG. 8 is a perspective view of an alternative embodiment of the heartvalve ring sizing tool of the present invention with the rings lockedtogether;

FIG. 9 is a perspective view of a second alternative embodiment of theheart valve ring sizing tool of the present invention with the ringsseparated;

FIG. 10 is a perspective view of a second alternative embodiment of theheart valve ring sizing tool of the present invention with the ringslocked together;

FIG. 11 is a perspective view of a third alternative embodiment of theheart valve ring sizing tool of the present invention that use a handlewith a flexible shaft attached to the outer ring with a removable innerring;

FIG. 12 is a perspective view of a fourth alternative embodiment of theheart valve ring sizing tool of the present invention that uses a handlefor each of the inner ring and the outer ring; and

FIG. 13 is a perspective view of a fifth alternative embodiment of theheart valve ring sizing tool of the present invention that includes aunitary inner and outer ring attached to a single handle.

DESCRIPTION OF THE PREFERRED EMBODIMENT

The present invention is described generally for mitral heart valverepair surgery. But it is to be understood that the present inventionmay be adapted for use on tricuspid valve repair and aortic root/annulusremodeling procedures (such as Tirone David type-operations) where thepresent invention may be used to simulate down-sizing the aortic root aswould be created by tube graft material.

The proposed device will: 1) provide a quick, more realistic, useful,functional, true-measurement of mitral annulus size, and 2) allow forcritical physiologic assessment of valve function (and consequently therepair quality) prior to final and permanent ring selection and allowfor such physiologic measurement and assessment using several differentring sizes and/or different ring models and shapes.

The key to proper/improved ring selection is not “just guessing” afterestimation of size and shape based on examination/measurement ofvisualized anatomy but on the potential information gained fromassessment of actual physiologic consequences secondary to ringimplantation. The proposed device will allow for a quick assessment ofthe valve annulus/repair with the ability to then again quickly assessthe same repair with a different sized or shaped device representing acorresponding different sized/shaped ring prior to final selection.

A key feature of this device is that an evaluation of valve physiology(i.e. testing a particular size and shape ring on the valve) can beobtained prior to commitment to a particular ring, which, under normalcircumstances, is then (permanently) sewn into position. Currently, itis only after the ring is sewn into position, that the valve's repairstatus can be optimally assessed intraoperatively.

The principal design would feature a device which quickly “captures” andaligns the ring sutures after they have been placed in the mitral valveannulus and after any complex repair had been completed such asquadrangular resection, etc. The alignment/positioning of the ringsutures would be such that the annulus size and shape, corresponding toa particular ring, would be essentially reproduced for the purpose of aquick, accurate assessment of function of the new post-repairphysiology, degree of leaflet coaptation, etc. The device could bequickly exchanged for another similar device which represents thedifferent size and/or shape of another ring. If several suchmeasurements can be executed efficiently and safely, the surgeon will bemuch more informed and secure in his decision regarding ring selectionas it will be based, at least to a significant degree, on actualmeasurement and more importantly on actual physiologic assessment.

It is the hope that such preliminary physiologic assessment willtranslate into the best final outcome for the patient. The addedinformation provided by quick and more accurate assessment of valvefunction, as described above, has the potential to significantlydiminish the dreaded consequence of having to entirely remove andreplace a poorly functioning valve ring/repair after separation frombypass and realization that the valve repair is functioningsub-optimally (or that a sub-optimal repair is left in place and“accepted” even though the surgeon is clearly unhappy with thesuboptimal result). “Undersizing” of the annulus can also be betteravoided and thus reduce the incidence of the unfavorable complication of“SAM” (systolic anterior motion) or having suboptimal hemodynamics froma smaller valve orifice or ring prosthesis shape.

The described functions of this device can be achieved in a variety ofways. Referring now to FIGS. 1-2, a first embodiment 10 of the heartvalve sizing tool of the present invention includes two rings 12, 14which “snap” together. The outer ring 12 could be incomplete, having asmall gap 15, to allow it to be used to gather all of the annularsutures within the outer ring 12 in a quick and easy manner (as shown inFIG. 4). The inner ring 14 would be complete and would “snap” into theslightly larger outer ring 14. In doing so, the two rings 12, 14 wouldfirmly, yet without damage to suture material, capture all sutures 16 inbetween the two rings 12, 14 (best seen in FIGS. 5 and 6). The devicecould then be “seated” into position (at annular level) in a fashionthat mimics the function of a particular ring.

The inner ring 14 preferably includes a concave surface 18 on the outerportion of the ring 14. The outer ring 12 preferably includes acomplimentary convex surface 20 on the inner portion of the ring 12. Theconcave and convex surfaces 18, 20 couple together to hold the rings 12,14 in an assembled state as shown in FIG. 3. Because the inner ring 14includes a concave surface 18 and the outer ring 12 includes a convexsurface 20, the sutures 16, when captured between the rings 12, 14, aredeflected outwards and away from the heart valve 22 permittingassessment of the physiology by being able to better view the fit.

The inner ring 14 and outer ring 12 may each optionally include a tab24, 26, respectively, extending from a portion of the ring 12, 14,preferably the bottom portion, to enable forceps to position and pullapart the two rings 12, 14. The tabs 24, 26 may be angled away from thecenter of the rings 12, 14 for easier gripping and manipulation.

Each particular device would correspond to a particular ring product ofspecified size and shape reproducing anticipated valve physiology shouldthat particular ring size/shape be selected. The valve repair could be“tested” in standard fashion by “pressurizing” with saline, byexamination, and/or by other techniques. When ring function isreproduced in this manner, leaflet coaptation, as well as success ofrepair techniques, can be evaluated and compared at various ringsizes/shapes prior to final selection of the optimal, simply by swappingout the sizing device for one of different size/shape. Several differentring sizes(/shapes) could be quickly swapped in and out for evaluationallowing for an informed, objective decision to be made. The devicecould be made of a variety of materials. Standard considerations wouldof course apply such as cost, bioreactivity, etc.

Ideally the device would be composed of a material which would notharm/damage/weaken/fray sutures. One such example of the device would betwo hard (metal, plastic, etc.) rings with a soft rubber-like outerlayer on each. The metal, or other similar firm material, would providesupport and accuracy in size and shape, while the outer rubber, orsimilar material with resilient properties, layer would not onlyprotect, but also, delicately, yet firmly, “grasp” the sutures betweenthe two rings. Ideally, the “grip” on the sutures would be such thatdevice would not slip over the sutures passively but could actively beslid by the surgeon across the sutures to allow for seating into thedesired position up against the valve annulus.

In one embodiment of the heart valve sizing tool would be “stiff” toapproximate the function of a “stiff” ring (possibly metal, plastic,etc). Though, other versions may exist to best approximate thephysiologic support provided by various other types of rings (soft,partial, etc.). Ideally each size and variety/shape of mitral ring mighthave its own version of a sizing device. Optionally, to facilitate ringseparation, small tabs (or similar structures) could be attached to eachring. The device may also be constructed in one of several other formsall of which achieve the previously stated general goals, but possiblywith certain advantages or features.

Another embodiment of the device could be a solid “double-ring” designas one single (connected) unit. The inner ring would be solid 360degrees, while the outer ring would be near 360 degrees (with a smallaccess slit for example). This would allow the surgeon to gather allsutures with a single 360 degree “twirl” motion of the device. Once allsutures had been captured, the device could be pushed up against themitral annulus (with some tension on the sutures). Variations on thisparticular design may include some form of mechanism which activelysecures the sutures between the two rings by opposing one ring closelyto the other after the sutures had been gathered. Examples couldinclude, but are not limited to: one ring sliding (down the handle, asshown in FIGS. 7 and 8) onto the other ring, +/−locking down onto theother ring. Such functions may be operated by various mechanisms,including but not limited to, twisting mechanism which tightens one ringagainst the other, a sliding+/−locking mechanism which could beoperated, for example, by the surgeon's thumb and two fingers (similarmotion as for a syringe).

In another embodiment 100, a the heart valve sizing tool includes ahandle 102 (best seen in FIGS. 7 and 8), similar to those used forvalves/rings and may be useful with seating the device up against theannulus as well as facilitate other motions such as gathering sutures. Ahandle for the device could take one of several forms. The handle couldbe flexible, bendable, detachable (for example FIGS. 11 and 12 thehandle may be removed from the heart valve sizing tool), etc. The handle102 could facilitate manipulation and handling of the device. It wouldideally provide optimal visualization of the valve leaflets forinspection as well as “testing” for leakage. The handle 102 couldinclude a trigger 104 to force the inner ring 14 into position withinthe outer ring 12 once the sutures 16 are gathered within the outer ring12. Pulling the trigger 104 pushes a shaft 106, which has the inner ring14 attached on an end thereof. The outer ring 12 is attached to a secondshaft 108 in a fixed position. Full deflection of the trigger 104 alignsthe inner ring 14 within the outer ring 12. The inner and outer ring 12,14 of a particular size may be exchanged from the handle 102 to thedesired size.

In a second alternative embodiment 200, a heart valve sizing toolincludes a syringe-type handle 202 (best seen in FIGS. 9 and 10). Asyringe-type handle 202 for the device could take one of several forms.The syringe-type handle 202 would be flexible, bendable, detachable,etc. The syringe-type handle 202 could facilitate manipulation andhandling of the device. It would ideally provide optimal visualizationof the valve leaflets for inspection as well as “testing” for leakage.The syringe-type handle 202 includes a pair of rings 204 to support thedevice on the surgeon's index and ring fingers. A device is operatedwith via the surgeon's thumb. A thumb ring 206, attached to a shaft 208,forces the inner ring 14 into position within the outer ring 12 once thesutures are gathered within the outer ring 12. Pushing the thumb ring206 pushes the shaft 208, which has the inner ring 14 attached on an endthereof. The outer ring 12 is attached to a second shaft 210 in a fixedposition. Fully depressing the thumb ring 206 aligns the inner ring 14within the outer ring 12. The inner and outer ring 12, 14 of aparticular size may be exchanged from the handle 202 to the desiredsize. Pulling on the thumb ring 206 separates the inner ring 14 from theouter ring 12.

Referring to FIG. 11, a third alternative embodiment 300 of the heartsvalve sizing tool is shown generally. The tool 300 includes a handle 302with one or more shafts 304. The shafts 304 may be flexible or rigid. Atthe end of each shaft 304 is an outer ring 12, each of different andadjacent sizes. Each outer ring 12 has a matching and separable innerring 14 as described above for the first embodiment 10. The inner ring14 may be inserted and removed with forceps. The inner rings 14 may alsohave a handle 306 extending therefrom with a flexible or rigid shaft 308as well, to remove the need for the use of forceps to insert and removethe inner ring 14 from the outer ring 12 as seen in FIG. 12.

Referring now to FIG. 13, a fifth embodiment 400 could be in the form ofa single device on a handle 402 that includes a flexible or rigid shaft404. Sutures 16 are gathered in a circular motion of the hand within achannel 406 formed between the inner ring 414 and the outer ring 412.The rings 412, 414 are “pushed up against” the valve annulus via thehandle 402 for sizing and intraoperative testing of the valve repair.The inner ring 414 and the outer ring 412 may also be hinged together topermit the inner ring 414 to be swung out the way. The handle 402 may beremovable also. The hinge mechanism functions in place of snapping thetwo rings together, as in the other embodiments, and provides ease ofgathering sutures 16 while still retaining the quality of gentlygripping the sutures 16 as the other embodiments described above.

In all embodiments, access for sutures through the outer ring can be inthe form of a simple defect. Possibly one variant would provide fortemporary exposure of a defect created by a quick “bending-apart” of thering which would then “spring-back” into its original shape of whatappears to be a complete ring (possibly facilitated by a mechanism toopen the device). Alternatively, a small defect can simply remainuncovered, or a small latch can cover the defect, or the outer layer canslide over the defect.

Various mechanisms can be employed to hold the device (via the sutures)firmly up against the annulus. The simplest form may be simple frictionprovided by a rubber-like coating as described above. Though, othermechanisms/materials may provide a similar function.

It would be appreciated by those skilled in the art that various changesand modifications can be made to the illustrated embodiments withoutdeparting from the spirit of the present invention. All suchmodifications and changes are intended to be within the scope of thepresent invention.

I claim:
 1. A device for measuring heart valve for sizing a heart valvereinforcement ring, comprising: a handle having a first shaft and asecond shaft; an inner ring coupled to the first shaft; an outer ringcoupled to the second shaft; and a trigger mechanism configured andarranged to force the inner ring and outer ring together wherein anouter surface of the inner ring engages an inner surface of the outerring; the inner surface of the outer ring and the outer surface of theinner ring having reciprocal mating surfaces configured and arranged togrip sutures therebetween when coupled together.
 2. The device of claim1, wherein the outer ring further comprises a defect forming a break inthe outer ring.
 3. The device of claim 1, wherein the inner surface ofthe outer ring is concave, and the outer surface of the inner ring isconvex.
 4. The device of claim 1, wherein the handle is flexible.
 5. Thedevice of claim 1, wherein the handle is bendable.
 6. The device ofclaim 1, wherein the handle is detachable.
 7. The device of claim 1,wherein the trigger mechanism is configured and arranged to move thefirst shaft and inner ring into coupled relation with the outer ring. 8.The device of claim 7, wherein the trigger mechanism is configured andarranged to push the first shaft and inner ring into coupled relationwith the outer ring.
 9. The device of claim 1, wherein the second shaftis in a fixed position and the first shaft is movable.
 10. The device ofclaim 1, wherein pulling the trigger mechanism pushes the first shaft.11. The device of claim 1, wherein the trigger mechanism is squeezable.12. The device of claim 1, wherein the trigger mechanism comprises athumb ring.
 13. The device of claim 1, where the handle furthercomprises a pair of finger rings.